Effects of Mesenchymal Stem Cell Supernatant on Prevention and Treatment of Skin/Mucosal Injury in Hematology Patients

NCT06599346 | Recruiting

• 1 other identifier: 2023EC4-ky008
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is studying the effects of mesenchymal stem cell (MSC) culture supernatant on the prevention and treatment of mucosal injuries in patients undergoing hematopoietic stem cell transplantation (HSCT). HSCT is a common treatment for blood-related cancers and other serious blood disorders. However, many patients experience severe damage to their mucous membranes, including the lining of the mouth, skin, and bladder, due to the high-dose chemotherapy used in the treatment process. These mucosal injuries can cause pain, increase the risk of infection, and lower the patient's quality of life. The purpose of this study is to determine whether MSC culture supernatant can help repair mucosal injuries and improve recovery for these patients. MSC culture supernatant contains substances produced by mesenchymal stem cells that may promote healing and reduce inflammation. These substances could potentially repair tissue without the risks associated with using live cells. Participants in this trial will be randomly assigned to one of two groups: one group will receive standard care, and the other will receive MSC culture supernatant as part of their treatment. The study will look at how well MSC supernatant helps heal mucosal injuries, as well as its safety and any side effects that may occur. The outcomes of this study could lead to new ways to prevent and treat mucosal injuries in patients undergoing HSCT, improving their quality of life during and after treatment. The trial will include 120 patients who have undergone HSCT and experienced mucosal injuries. The study will last approximately five years, from October 2020 to September 2025. Participants will be monitored throughout the trial for safety and effectiveness of the treatment, with follow-up visits scheduled to assess their progress.

Conditions

Mucositis; Hematopoietic Stem Cell Transplantation; Chemotherapy-Induced Mucositis; Radiation-Induced Mucositis

Keywords

Mesenchymal Stem Cell Supernatant; Mesenchymal Stem Cell Exosomes; Mucosal Injury; Hematopoietic Stem Cell Transplantation; Chemotherapy; Radiotherapy; Oral Mucosal Injury; Skin Mucosal Injury; Bladder Injury; HSCT Complications; Tissue Regeneration; Mucosal Repair

Outcome Measures

Primary Outcomes (1)

• Mucosal Injury Healing

  The degree of mucosal injury healing will be assessed using the WHO Mucosal Injury Scale (World Health Organization Mucosal Injury Grading Scale) and a pain score measured by the Visual Analog Scale (VAS) for pain. WHO Mucosal Injury Scale: This scale assesses mucosal injury severity. The grades range from 0 (no injury) to 4 (severe ulceration and bleeding). A lower score indicates better mucosal health. Visual Analog Scale (VAS) for pain: This scale measures pain on a range of 0 (no pain) to 10 (worst pain imaginable). A lower score indicates less pain. The outcome will measure the percentage of participants with WHO mucosal injury grades ≤1 and VAS pain scores ≤2, indicating mild or no injury and low pain.

  8 weeks after the start of treatment.

Secondary Outcomes (2)

• Mucosal Infection Rates

  From the start of treatment through 8 weeks post-treatment.

• Hospital Stay Duration

  From the start of treatment until discharge, assessed up to 12 weeks.

Other Outcomes (1)

• Patient Quality of Life (QoL)

  12 weeks after the start of treatment.

Study Arms (2)

Active Comparator: Standard Care for Mucositis

ACTIVE COMPARATOR

Participants in this arm will receive standard care for mucositis, which may include oral rinses, topical treatments, and supportive care. Standard care will be tailored based on the type and severity of the mucosal injury (oral, skin, or bladder).

Other: Standard Care

Experimental: MSC Supernatant + Standard Care for Mucositis

EXPERIMENTAL

Participants in this arm will receive MSC supernatant in addition to standard care for mucositis. The MSC supernatant will be administered as follows: 15 mL for oral mucosal injuries (mouthwash) Topical application for skin mucosal injuries (based on body surface area) 50 mL for bladder injuries (bladder irrigation)

Biological: MSC Supernatant + Standard Care

Interventions

Standard Care OTHER

Participants in this arm will receive standard care for mucosal injuries, which may include oral rinses, topical treatments, and supportive care based on the type of injury.

Active Comparator: Standard Care for Mucositis

MSC Supernatant + Standard Care BIOLOGICAL

Participants in this arm will receive MSC supernatant in addition to standard care. MSC supernatant will be administered as follows: 15 mL for oral mucosal injuries (mouthwash) Topical application for skin mucosal injuries (based on body surface area) 50 mL for bladder injuries (bladder irrigation)

Experimental: MSC Supernatant + Standard Care for Mucositis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18 years or older.
• Patients who have undergone hematopoietic stem cell transplantation (HSCT).
• Patients who have developed mucosal injuries (oral, skin, or bladder) after HSCT, chemotherapy, or radiotherapy.
• Patients who are willing to provide informed consent and comply with the study procedures.

You may not qualify if:

• Patients with severe organ dysfunction (e.g., heart, liver, kidney failure) that could interfere with the study.
• Patients with uncontrolled active infections.
• Known allergies or hypersensitivity to MSC supernatant.
• Pregnant or breastfeeding women.
• Patients with HIV or active hepatitis B or C infections.
• Patients who have participated in another clinical trial within the last 4 weeks.

Sponsors & Collaborators

• The General Hospital of Western Theater Command: lead

Study Sites (1)

Department of Hematology, The General Hospital of Western Theater Command

Chengdu, Sichuan, 610083, China

RECRUITING

MeSH Terms

Conditions

Mucositis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dan Chen, Bachelor

  Department of Hematology, The General Hospital of Western Theater Command

  PRINCIPAL INVESTIGATOR

• Hao Yao, Ph.D

  Department of Hematology, The General Hospital of Western Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Yao, Ph.D

CONTACT

+86-028-86571286; yaohao9001@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants in this study will be randomly assigned to one of two groups in parallel. The control group will receive standard care for mucosal injuries (such as oral rinses and supportive care), while the intervention group will receive MSC supernatant treatment in addition to standard care. The treatments will be administered concurrently, and both groups will be monitored for the duration of the study to assess the effectiveness and safety of MSC supernatant in healing mucosal injuries caused by HSCT, chemotherapy, and radiotherapy.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)